Autism Spectrum Disorder (ASD), Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Portable Sleep Monitor, Polysomnogram, Children with ASD, Nox T3s, Sleep Disordered Breathing, Sleep disorder
Brief summary
The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to: 1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG); 2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA); 3. Evaluate patient and family preferences for sleep testing.
Detailed description
Sleep disorders are highly prevalent in children with ASD, with as many as 80% of children reporting poor sleep. To identify the cause of poor sleep, many children will require a sleep study (polysomnogram; PSG), which is an overnight study done at the hospital using many different sensors to measure sleep and breathing. The PSG is the gold standard diagnostic test for obstructive sleep apnea (OSA) and measures the rate of obstructive respiratory events during sleep (obstructive apnea-hypopnea index; OAHI) which is crucial for treatment decision-making. However, PSGs are challenging for children with ASD due to the disrupted routine, burden and stress, and intolerance to the PSG setup. Further, diagnosis may be delayed up to 2 years due to a lack of pediatric sleep facilities in Canada, with pronounced geographical disparities. Although sleep disturbances are prevalent amongst children with ASD, there are significant inequities in accessing pediatric sleep medicine care and diagnostic testing. Alternative, simpler diagnostic testing is needed. We will evaluate a portable sleep monitor as the first step towards establishing home sleep apnea testing in children with ASD. We will conduct a feasibility study testing the Nox T3s portable sleep monitor alongside the traditional in-hospital polysomnogram to compare the ability of the Nox T3s to identify obstructive sleep apnea in children with ASD. We will also conduct qualitative interviews with families to gather insight on participant and family preferences for sleep testing to better address the needs of children with ASD.
Interventions
DEVICEPortable sleep monitor (Nox T3s)
Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.
Sponsors
Lena Xiao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Children between 6 to 18 years of age, AND; 2. Children diagnosed with autism spectrum disorder, AND; 3. Children who will be undergoing a polysomnogram (PSG) for the first time, AND; 4. Caregiver willing to complete questionnaires about child's sleep and behavior
Exclusion criteria
1. Children who are currently using respiratory therapy 2. Children who have previously completed a PSG 3. Caregiver unwilling to complete questionnaires about child's sleep and behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG) | Baseline | The OAHI measured from the portable sleep monitor will be compared to the OAHI measured from the PSG, the gold standard test for sleep-disordered breathing, to determine the ability of the portable sleep monitor to diagnose obstructive sleep apnea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Family Preferences | 0-3 months after the baseline PSG | Optional semi-structured qualitative interviews with caregivers and the patient, if they choose to and are capable of participating in the interviews. The interviews will be conducted virtually by a study team member to explore patient and family preferences and experiences with diagnostic sleep testing. |
| Insomnia Questionnaire | +/- 1 week from baseline PSG sleep test | The caregiver-reported Pediatric Insomnia Severity Index will be used to measure the severity of pediatric insomnia symptoms. Scores range from 0 to 30, with higher scores indicating greater insomnia severity. |
| Chronotype Questionnaire | +/- 1 week from baseline PSG sleep test | The caregiver-reported Children's Chronotype Questionnaire will measure the chronotype of the participant. The caregiver is given a short description of different chronotypes and selects the chronotype that best reflects their child's preference from a 5-point scale, ranging from "Definitely a Morning Type" = 1 to "Definitely an Evening Type" = 5. |
| Sleep Questionnaire | +/- 1 week from baseline PSG sleep test | The caregiver-reported Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorders subscale will measure the risk for sleep-related breathing disorders. The questionnaire contains 22-items scored as "yes" = 1 and "no" = 0 and normalized to the total number of questions answered, yielding a score between 0.0-1.0. Scores \>0.33 indicate a high risk for sleep-related breathing disorders. |
| Psychological Scale (Emotional Symptoms) | +/- 1 week from baseline PSG sleep test | The Emotional Symptoms subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater emotional difficulties. |
| Psychological Scale (Conduct Problems) | +/- 1 week from baseline PSG sleep test | The Conduct Problems subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater conduct difficulties. |
| Psychological Scale (Hyperactivity/inattention) | +/- 1 week from baseline PSG sleep test | The Hyperactivity/inattention subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater hyperactivity/inattention problems. |
| Psychological Scale (Peer Relationship Problems) | +/- 1 week from baseline PSG sleep test | The Peer Relationship Problems subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater peer relationship problems. |
| Psychological Scale (Pro-Social) | +/- 1 week from baseline PSG sleep test | The Pro-Social subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating less difficulty and an increased aptitude for kind and helpful behaviour. |
| Psychological Scale (Total Difficulties) | +/- 1 week from baseline PSG sleep test | The Total Difficulties/Overall Stress scale of the Strengths and Difficulties Questionnaire will be calculated by totaling the following 4 subscales: emotional, conduct, hyperactivity, and peer relationships. The total score ranges from 0-40, with greater scores indicating greater difficulties and overall stress. |
| Sensory Scale (Auditory Hypersensitivity) | +/- 1 week from baseline PSG sleep test | The Auditory Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 9-36, with greater scores indicating higher sensitivity for, and problems with, sounds related to auditory danger signals. |
| Sensory Scale (Auditory Hyposensitivity to Voices) | +/- 1 week from baseline PSG sleep test | The Auditory Hyposensitivity to Voices subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 5-20, with greater scores indicating reduced sensitivity for speech or voices. |
| Sensory Scale (Visual Hypersensitivity) | +/- 1 week from baseline PSG sleep test | The Visual Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 10-40, with greater scores indicating increased sensitivity to light and movement. |
| Sensory Scale (Tactile Hypersensitivity) | +/- 1 week from baseline PSG sleep test | The Tactile Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 10-40, with greater scores indicating increased sensitivity to non-social touch. |
| Sensory Scale (Affiliative Touch Aversion) | +/- 1 week from baseline PSG sleep test | The Affiliative Touch Aversion subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 3-12, with greater scores indicating increased negative response to social touch. |
| Sensory Scale (Selective Eating) | +/- 1 week from baseline PSG sleep test | The Selective Eating subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 6-24, with greater scores indicating increased selectivity in food choices (i.e. picky eating). |
| Sensory Scale (Ingestive Problems) | +/- 1 week from baseline PSG sleep test | The Ingestive Problems subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 3-12, with greater scores indicating increased problems with swallowing and retaining food. |
| Sensory Scale (Digestive Problems) | +/- 1 week from baseline PSG sleep test | The Digestive Problems subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 4-16, with greater scores indicating increased problems with digestion. |
| Autism Symptoms Dimensions Scale | +/- 1 week from baseline PSG sleep test | The caregiver-reported Autism Symptoms Dimensions Scale (ASDS) will be used to measure core autism symptoms in children and adolescents. The 39-item questionnaire is scored on a 5-point scale with total ASDS scores ranging from 39-195. Scores between 114-130 indicate high symptom levels and scores \>130 indicate very high symptom levels. |
Countries
Canada
Contacts
CONTACTLena J Xiao, MD MSc
CONTACTMacyn LY Leung, MSc
Outcome results
None listed